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565,336 Results for "leiter s compounding".
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FDA
FDA Demurs on GLP-1 Compounding Fight, Debuts Consumer ‘Green List’ Instead
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
September 8, 2025
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2 min read
·
Annalee Armstrong
FDA
FDA Takes Long Overdue Baby Step Toward Regulating Compounder Drug Ads
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
September 17, 2025
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7 min read
·
Annalee Armstrong
Press Releases
Kiora Pharmaceuticals Granted U.S. Patent Covering Additional Formulations for the KIO-100 Family of Anti-Inflammatory Compounds
December 1, 2025
·
4 min read
Press Releases
Mabylon AG Initiates Phase I Clinical Trial of Lead Compound MY006 for the Treatment of Peanut Allergy
- First study participant dosed in U.S. trial with healthy volunteers and patients with peanut allergy - Novel, human-derived, half-life extended tri-specific monoclonal antibody to prevent allergic reactions
December 11, 2025
·
1 min read
GLP-1
A Compounding Problem: How GLP-1s Drove Novo Nordisk’s Rapid Rise and Fall
Novo Nordisk has plummeted back to Earth after a stunning rise driven by Ozempic and Wegovy. Can the storied Danish pharma recover?
August 13, 2025
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5 min read
·
Nick Paul Taylor
Drug shortages
FDA Confirms Lilly’s GLP-1s Are Not in Shortage, Gives Compounders Grace Period
After a couple months of uncertainty, the FDA has told compounding pharmacies that they have 60 to 90 days before the agency will enforce rules to stop their production of GLP-1s.
December 19, 2024
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3 min read
·
Tristan Manalac
Legal
Judge Rules Against Semaglutide Compounders After Shortage Declared Over
Big compounders will have until May 22 to stop producing and dispensing compounded semaglutide, while smaller, state-run pharmacies must immediately stop making copies of the blockbuster drug.
April 25, 2025
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2 min read
·
Tristan Manalac
Podcast
Trump’s Pharma Tariffs, Another GLP-1 Compounding Lawsuit, Bluebird’s Bailout, More
As FDA seeks to rehire some fired employees, Donald Trump threatens to enact tariffs on pharma companies unless they reshore manufacturing; another lawsuit hits the complex GLP-1 compounding space as Eli Lilly offers expanded Zepbound options; and struggling gene therapy biotech bluebird bio goes private in an attempt to stay solvent.
February 26, 2025
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1 min read
·
Heather McKenzie
Press Releases
Compounding Pharmacy Market Size Worth USD 31.77 Bn by 2034 Personalized Medicine Demand Accelerates
December 9, 2025
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1 min read
Weight loss
Novo Nordisk’s Termination of Hims & Hers Deal Reignites Compounding Row
Analysts said the deal with Novo was likely giving Hims “‘credibility’ or increased consumer traffic,” adding that the “litigation risk is back on the table” now that the Danish pharma has stepped away.
July 9, 2025
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4 min read
·
Nick Paul Taylor
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